Clinical Study of the Effectiveness, Tolerability and Safety of the Drug "Anti-spike, Gel, 100 g in Bottles in Package No. 1" Produced by the Republican Unitary Enterprise "Unitekhprom BSU", With a Single Intraperitoneal Use After Surgery in Adult Patients With Acute Phlegmonous Appendicitis

Phase 2Active Not RecruitingNCT06365632

Research Institute for Physical Chemical Problems of the Belarusian State University100 enrolled

Overview

The purpose of the clinical trials is the evaluation of the effectiveness and safety of a single intraperitoneal use of the drug "Antispike, gel, 100 g in a bottle" produced by Unitary Enterprise Unitehprom BSU, Belarus in patients after surgical control of acute phlegmonous appendicitis to prevent abdominal adhesions.

The prospective, randomized, placebo-controlled, single-blind clinical trial of the effectiveness, tolerability and safety of the drug "Antispike, gel, 100 g in a bottle" produced by Unitary Enterprise Unitehprom BGU, Republic of Belarus, in adult patients after surgery for acute phlegmonous appendicitis. Research objectives: * To evaluate the immediate, rapid and long-term results of using Antispike as a drug for preventive adhesions in patients who have a medium and high risk factor for the development of adhesions and are undergoing surgery for acute phlegmonous appendicitis; * Identify the possibility of undesirable effects that may occur when using the drug; * to conduct a comparative assessment of the immediate results of using the drug Antispike as a means of preventing adhesions in patients with minor phlegmonous appendicitis with an effect in the control group, in patients in whom anti-adhesion drugs were not used; * Detailed description of the conditions and method of use of the Antispike drug.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Enrollment

100

Conditions

Abdominal Adhesions

Interventions

Antispike gel, 100 g in a flask, produced by UNITEHPROM BSU, Republic of BelarusDRUG

An antegrade appendectomy is performed, after which 50 to 100 ml of Antispike is applied in a thin layer to the surface of the cecum, the surface of adjacent organs and the parietal peritoneum of the right iliac region. The wound is sutured tightly.

antegrade appendectomyPROCEDURE

An antegrade appendectomy is performed without using Antispike.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Presence of acute phlegmonous appendicitis requiring surgical intervention. * Presence of medium or high risk factor for the development of adhesions of the abdominal cavity; * Age of patients from 18 to 65 years. * Absence of severe concomitant diseases in decompensation stage, oncologic diseases, as well as diseases requiring steroid therapy. * Presence of written informed consent of the patient to participate in the study. * The patient's ability to fulfill the instructions of the research physician and comply with the study design. Exclusion Criteria: * At the subject own request without explaining the reasons for the behavior. * At the request of the physician-researcher if the subject violates the requirements of the protocol in terms of diet, smoking, consumption of alcoholic beverages, and use of medications without the prescription of the physician-researcher. * For reasons independent of the subject and the research physician, if the subject has drug intolerance or other life-threatening or life-threatening adverse reactions to drug administration that require emergency pharmacotherapy.

Outcomes

Primary Outcomes

Number of patients with acute phlegmonous appendicitis cured

Number of patients cured

Time frame: from surgery to 3 weeks

Secondary Outcomes

absence of signs of adhesions

absence of signs of adhesions according to clinical and ultrasound studies

Time frame: from surgery to 4 weeks